This article discusses the key elements of the EU MDR pertaining to drug device combination products and how life science companies can organize themselves to ensure regulatory compliance is met. The ...

Teva received approval for Uzedy which is a long acting risperidone to treat schizophrenia. For this drug, Teva was looking for a way to improve the patient journey and outcomes for this specific ...

The new Quality Management System Regulation (QMSR) that became effective on February 2, 2026, includes significant changes in the regulatory framework for combination drug-device and biologic-device ...

The "Drug Device Combination Products Market by Type (Injectable, Transdermal Patch, Infusion Pump, Drug-eluting Stent, Inhaler), Application (Diabetes, Oncology, Pain, Opthalmology), End User ...

Johnson & Johnson (J&J), Allergan, Pfizer and industry group BIO’s suggestions to the US Food and Drug Administration’s (FDA) new Combination Product Policy Council released Monday build on efforts ...

Device and pharmaceutical manufacturers must understand the differences in scientific expectations and cultural environments between CDRH and CDER to obtain FDA approval of drug-device combination ...

The "Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course (Mar 2nd - Mar 3rd, 2026)" training has been ...

With each passing year, combination products are growing in importance. However, because they represent a marriage between traditionally discrete technology and market sectors--the medical device and ...

CARLSBAD, Calif.--(BUSINESS WIRE)--Today, Argonaut Manufacturing Services (“Argonaut”), a US-based sterile fill-finish CDMO, and Ensera, a CDMO with facilities in the US, and Europe and Asia, ...

Boston and San Francisco-based Pear Therapeutics, not to be confused with Pear Sports, has raised an undisclosed sum in a round led by 5AM Ventures. The company has developed a product called ...

Combination products present a tremendous opportunity to improve health outcomes, because they leverage multiple disciplines. If we were, for example, to focus on drugs alone with little thought to ...

Ensera and Argonaut Partner to Streamline Supply for Drug-Device Combination Products Delivering an integrated fill-finish and device assembly and packing collaboration to reduce complexity and ...